Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator? (PARTITA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by IRCCS San Raffaele
Sponsor:
Information provided by (Responsible Party):
Paolo Della Bella, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01547208
First received: February 28, 2012
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to assess whether if the burden of untreated non-sustained ventricular tachycardias (VTs), or episodes treated with anti-tachycardia pacing, correlates with appropriate implantable cardiac defibrillator (ICD) shock therapies and to evaluate if the timing of radiofrequency VT ablation affects the prognosis of ICD recipients.


Condition Intervention
Ventricular Tachycardias
Procedure: Immediate radiofrequency ablation of ventricular tachycardia
Procedure: Radiofrequency ablation of ventricular tachycardia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • Occurrence of the first appropriate ICD shock during phase A [ Time Frame: Event Driven ] [ Designated as safety issue: No ]
  • Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B [ Time Frame: Two Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients showing cardiac deaths during phase B [ Time Frame: Two Years ] [ Designated as safety issue: No ]
  • Number of patients showing electrical storm (ES) recurrences during phase B [ Time Frame: Two Years ] [ Designated as safety issue: No ]
  • Number of patients showing VT recurrences during phase B [ Time Frame: Two Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 590
Study Start Date: September 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Patients will be randomized to a VT ablation procedure immediately after an appropriate ICD shock
Procedure: Immediate radiofrequency ablation of ventricular tachycardia
Radiofrequency ablation of ventricular tachycardia is performed immediately after an appropriate ICD shock
Active Comparator: Group B
Patients will wait until an arrhythmic storm to undergo a VT ablation procedure
Procedure: Radiofrequency ablation of ventricular tachycardia
Radiofrequency ablation of ventricular tachycardia will be performed after an arrhythmic storm occurs

Detailed Description:

Enrolled patients will remain in a first phase of the study until the first appropriate ICD shock will be delivered.

The objective of this first stage is to assess whether the burden of untreated non sustained VTs or episodes treated with anti-tachycardia pacing is predictive of appropriate ICD shocks.

The second phase of the study will start after the first appropriate ICD shock delivered for VT.

Patients will be then randomized to immediate VT ablation or to standard treatment, meaning waiting until next arrhythmic storm to perform a VT ablation procedure.

The objective of this phase is compare the rate of worsening heart failure hospitalizations and deaths from any cause between the two groups.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients already implanted with ICD (single-/dual -chamber, with or without cardiac resynchronization therapy) for primary or secondary prevention of sudden cardiac death

Exclusion Criteria:

Phase A exclusion Criteria:

  • General contraindication to transcatheter ablation
  • Contraindication to antithrombotic therapy
  • Patients chronically treated with class I and III antiarrhythmic drugs

Phase B exclusion criteria:

  • Patients developing first occurrence of incessant VTs
  • Patients receiving a shock for first occurrence of clinically verified ventricular fibrillation
  • Patients with aetiology differing from ischemic heart disease for coronary artery disease and from non-ischemic dilatative cardiomyopathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547208

Contacts
Contact: Pasquale Vergara pasqualevergara@yahoo.it
Contact: Paolo Della Bella dellabella.paolo@hsr.it

Locations
Czech Republic
IKEM Hospital Not yet recruiting
Prague, Czech Republic
Contact: Josef Kautzner         
Principal Investigator: Josef Kautzner         
France
Hôpital cardiologique du Haut-Lévêque Not yet recruiting
Bordeaux, France
Contact: Pierre Jais         
Principal Investigator: Pierre Jais         
Germany
Herz und Gefass Klinik Not yet recruiting
Bad Neustadt, Germany
Contact: Thomas Deneke         
Principal Investigator: Thomas Deneke         
Italy
Ospedale Oglio Po Not yet recruiting
Casalmaggiore, Cremona, Italy
Contact: Annalisa Perrini         
Principal Investigator: Annalisa Perrini         
Ospedale di Desio Not yet recruiting
Desio, Milan, Italy
Contact: Giuseppe Mantovani         
Principal Investigator: Giuseppe Mantovani         
Ospedale di Montebelluna Recruiting
Montebelluna, Treviso, Italy
Contact: Diego Vaccari         
Principal Investigator: Diego Vaccari         
Ospedale Mater Domini Not yet recruiting
Castellanza, Varese, Italy
Contact: Massimo Tritto         
Principal Investigator: Massimo Tritto         
Azienda Ospedaliera Sant'Antonio Abate Not yet recruiting
Gallarate, Varese, Italy
Contact: Daniela Orsida         
Principal Investigator: Daniela Orsida         
Principal Investigator: Ivan Caico         
Ospedale di Mirano Not yet recruiting
Mirano, Venice, Italy
Contact: Franco Zoppo         
Principal Investigator: Franco Zoppo         
Ospedale S. Donato Recruiting
Arezzo, Italy
Contact: Pasquale Notarstefano         
Principal Investigator: Pasquale Notarstefano         
Ospedale Cardinal Massaia Not yet recruiting
Asti, Italy
Contact: Domenico Caponi         
Principal Investigator: Domenico Caponi         
AO Policlinico di Bari Not yet recruiting
Bari, Italy
Contact: Giuseppe Grandinetti         
Principal Investigator: Giuseppe Grandinetti         
Ospedale Brotzu Not yet recruiting
Cagliari, Italy
Contact: Gianfranco Tola         
Principal Investigator: Gianfranco Tola         
Osp. Fondazione Giovanni Paolo II Recruiting
Campobasso, Italy
Contact: Matteo Santamaria         
Principal Investigator: Matteo Santamaria         
AO Pugliese Ciaccio Recruiting
Catanzaro, Italy
Contact: Giampiero Maglia         
Principal Investigator: Giampiero Maglia         
Azienda Sanitaria Spezzino Not yet recruiting
La Spezia, Italy
Contact: Sandra Badolati         
Principal Investigator: Sandra Badolati         
IRCCS San Raffaele Recruiting
Milan, Italy
Contact: Pasquale Vergara       pasqualevergara@yahoo.it   
Principal Investigator: Paolo Della bella         
Principal Investigator: Pasquale Vergara         
Fondazione G. Monasterio Not yet recruiting
Pisa, Italy
Contact: Marcello Piacenti         
Principal Investigator: Marcello Piacenti         
Policlinico Casilino Not yet recruiting
Rome, Italy
Contact: Alessio Borrelli         
Principal Investigator: Leonardo Calò         
Principal Investigator: Alessio Borrelli         
Azienda Ospedaliera Valtellina e Valchiavenna Not yet recruiting
Sondrio, Italy
Contact: Maurizio Moizi         
Principal Investigator: Maurizio Moizi         
Ospedale Santa Maria Not yet recruiting
Terni, Italy
Contact: Stefano Donzelli         
Principal Investigator: Stefano Donzelli         
Principal Investigator: Giovanni Carreras         
Ospedale Civile Maggiore Not yet recruiting
Verona, Italy
Contact: Giovanni Morani         
Principal Investigator: Giovanni Morani         
Switzerland
Lausanne Hospital Not yet recruiting
Lausanne, Switzerland
Contact: Etienne P Pruvot         
Principal Investigator: Etienne Pruvot         
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Study Director: Paolo Della Bella IRCCS San Raffaele
Study Director: Pasquale Vergara IRCCS San Raffaele
  More Information

Publications:

Responsible Party: Paolo Della Bella, Director of Arrhythmia Department and Clinical
 Electrophysiology 
Laboratories, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01547208     History of Changes
Other Study ID Numbers: PARTITA
Study First Received: February 28, 2012
Last Updated: May 22, 2014
Health Authority: Italy: National Institute of Health

Keywords provided by IRCCS San Raffaele:
ICD shocks
Ventricular tachycardias ablation
Timing of ablation
Electrical storm
Arrhythmic storm

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014